MAUDE Adverse Event Report: O & M HALYARD, INC. HALYARD; GOWN, SURGICAL

Model Number	44674
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When unfolding and opening the sterile gown a piece of blue sticky tape was found inside the sterile package.

• Brand Name: HALYARD
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): O & M HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 19350722
• Report Number: 19350722
• Device Sequence Number: 7109640
• Product Code: FYA
• UDI-Device Identifier: 10680651446746
• UDI-Public: (01)10680651446746(17)280710(10)AH3191TO7
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024
• Report Date (Section F): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 44674
• Device Catalogue Number: 44674
• Device Lot Number: AH3191TO7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/22/2024